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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

SABRIL: 772 Adverse Event Reports & Safety Profile

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772
Total FAERS Reports
53 (6.9%)
Deaths Reported
180
Hospitalizations
772
As Primary/Secondary Suspect
6
Life-Threatening
1
Disabilities

First Report: 2010 · Latest Report: 20140618

What Are the Most Common SABRIL Side Effects?

#1 Most Reported
Drug dose omission
168 reports (21.8%)
#2 Most Reported
Convulsion
130 reports (16.8%)
#3 Most Reported
Drug ineffective
68 reports (8.8%)

All SABRIL Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug dose omission 168 21.8% 1 11
Convulsion 130 16.8% 5 54
Drug ineffective 68 8.8% 0 3
Death 35 4.5% 35 6
Pneumonia 31 4.0% 6 28
Incorrect dose administered 27 3.5% 0 2
Vomiting 26 3.4% 1 8
Somnolence 25 3.2% 0 3
Wrong technique in drug usage process 24 3.1% 0 0
Malaise 19 2.5% 1 10
Pyrexia 19 2.5% 0 12
Retinal toxicity 18 2.3% 0 0
Drug withdrawal convulsions 16 2.1% 0 3
Infantile spasms 15 1.9% 0 4
Irritability 13 1.7% 0 4
Abnormal behaviour 12 1.6% 0 0
Respiratory distress 12 1.6% 3 12
Visual impairment 12 1.6% 0 1
Agitation 11 1.4% 1 1
Fatigue 11 1.4% 0 2

Who Reports SABRIL Side Effects? Age & Gender Data

Average age: 11.0 years. Most reports from: US. View detailed demographics →

Is SABRIL Getting Safer? Reports by Year

YearReportsDeathsHosp.
2010 2 0 0
2011 4 3 2
2012 8 2 3
2013 106 8 40
2014 258 23 92

View full timeline →

What Is SABRIL Used For?

IndicationReports
Infantile spasms 389
Complex partial seizures 144
Epilepsy 110
Product used for unknown indication 103
Convulsion 26
Tuberous sclerosis 26
Temporal lobe epilepsy 21
Generalised tonic-clonic seizure 14
Grand mal convulsion 10
Generalised non-convulsive epilepsy 7

SABRIL vs Alternatives: Which Is Safer?

SABRIL vs SACCHAROMYCES CEREVISIAE SABRIL vs SACITUZUMAB GOVITECAN SABRIL vs SACITUZUMAB GOVITECAN-HZIY SABRIL vs SACROSIDASE SABRIL vs SACUBITRIL SABRIL vs SACUBITRIL\VALSARTAN SABRIL vs SAFINAMIDE SABRIL vs SAIZEN SABRIL vs SALICYLATE SABRIL vs SALICYLIC ACID

Official FDA Label for SABRIL

Official prescribing information from the FDA-approved drug label.